Actively Recruiting
Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC
Led by Medical University Innsbruck · Updated on 2022-08-24
33
Participants Needed
1
Research Sites
342 weeks
Total Duration
On this page
Sponsors
M
Medical University Innsbruck
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
The primary aim of this single arm, phase II study is to determine the efficacy of the combination therapy Pembrolizumab/Lenvatinib regarding the rate of major pathological response (MPR-Rate). The investigators expect to improve the MPR-Rate of 20% in Anti-PD1/-PD-L1 monotherapy (observed in recent trials) to a MPR-Rate of 40% with the combination therapy Pembrolizumab/Lenvatinib.
CONDITIONS
Official Title
Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older
- Histologically confirmed resectable NSCLC, stages IA3 to IIIA (maximum single station N2)
- Measurable disease according to RECIST 1.1 criteria
- Male participants must agree to use contraception during treatment and for at least 120 days after last dose, and avoid sperm donation during this period
- Female participants must not be pregnant or breastfeeding and either be not of childbearing potential or agree to use contraception during treatment and for at least 120 days after last dose
- Provided written informed consent
- ECOG performance status of 0 to 1
- Adequate organ function with samples collected within 14 days before starting treatment
You will not qualify if you...
- Women of childbearing potential with positive pregnancy test within 72 hours before inclusion
- Uncontrolled blood pressure (systolic >160 mmHg or diastolic >95 mmHg) despite treatment
- Significant cardiovascular diseases such as congestive heart failure (NYHA Class >II), unstable angina, recent myocardial infarction or stroke within 6 months, or cardiac arrhythmias requiring treatment
- History of prolonged QT syndrome or family history of it
- QTc interval greater than 490 msec averaged over 3 ECGs
- Bleeding or clotting disorders or risk of severe hemorrhage, especially with tumor invasion of major blood vessels
- Proteinuria greater than 1+ on urine dipstick unless 24-hour urine protein is less than 1 g
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T cell receptor agents
- Prior systemic anti-cancer therapy or radiotherapy for newly diagnosed NSCLC
- Live vaccine within 30 days before first dose of study drug
- Participation in investigational drug or device study within 4 weeks before first dose
- Immunodeficiency or chronic systemic steroid/immunosuppressive therapy within 7 days before first dose
- Active progressing additional malignancy
- Severe allergic or hypersensitivity reactions to Pembrolizumab, Lenvatinib, or their excipients
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis requiring steroids
- Active infection needing systemic therapy
- HIV, Hepatitis B or C infection
- Psychiatric or substance abuse disorders interfering with trial participation
- Prior surgery therapy for newly diagnosed NSCLC
- Pregnancy, breastfeeding, or planning to conceive or father children during study and 120 days after last dose
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Medical University Innsbruck
Innsbruck, Tyrol, Austria, 6020
Actively Recruiting
Research Team
K
KKS Innsbruck
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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